In patients with ST-segment elevation acute myocardial infarction (STEMI), primary percutaneous coronary intervention (PCI) is often not available or is subject to delays. The GRupo de Análisis de la Cardiopata Isquémica Aguda (GRACIA-2) study evaluated whether lytic-based early routine PCI was a reasonable option for STEMI patients.
The GRACIA-2 study randomly assigned 212 STEMI patients within 12 h of symptom onset to treatment with full tenecteplase followed by stenting within 3 to 12 h of randomisation (n=104) or to undergo primary stenting with abciximab within 3 h of randomisation (n=108).
The primary endpoint was post-PCI epicardial and myocardial reperfusion, and the extent of left ventricular myocardial damage (infarct size and left ventricular function at 6 weeks).
Secondary endpoints included acute bleeding, and the composite at 6 months of death, re-infarction, stroke, and repeat ischaemia-driven coronary revascularisation.
GRACIA-2: Study design
Thrombolysis followed by early routine PCI resulted in a higher incidence of complete epicardial and myocardial reperfusion (21% vs 6%, p=0.03) compared to primary PCI.
Both groups were similar in terms of the 6-month cumulative incidence of death, non-fatal re-infarction, disabling stroke, and ischaemia-driven revascularisation (9.6% versus 12%; p=0.57; relative risk 0.80; 95% confidence interval [CI] 0.37 to 1.74).
GRACIA-2: Study outcomes
- Thrombolysis plus early routine PCI is as safe as primary PCI and equivalent in terms of preserving myocardial function.
- Thrombolysis plus early routine PCI results in better and earlier myocardial reperfusion.
- If these findings are confirmed by larger-scale trials, the proportion of patients with STEMI who can benefit from PCI could increase dramatically.
- Fernandez-Aviles F, et al. Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial. Eur Heart J 2007;28:949-960.